Though the U.S. Food and Drug Administration (FDA) recently announced that some glucagon-like peptide-1 (GLP-1) agonist drugs, specifically tirzepatide (Zepbound^®, Mounjaro^®), are no longer in shortage, others continue to see high demand and low supply. As patients turn to other sources to obtain their medications, which are used to treat diabetes and obesity, they may encounter illegal counterfeits of these drugs. 

Fraudulent GLP-1s may contain incorrect dosages and/or ingredients that can cause complications or unintended outcomes. The Special Investigations Unit (SIU) at Prime Therapeutics (Prime) is committed to identifying and preventing instances of fraud, waste and abuse. 

That’s why the SIU is proud to release a new report that shares how to identify and avoid counterfeit GLP-1 medications. Our newsroom team caught up with Jessica Johnson, a clinical consultant for the SIU, to learn more about how Prime helps members stay safe when prescribed a GLP-1 medication. 

Prime: How does the shortage of GLP-1 drugs relate to the number or type of fraudulent cases? Do we see any shifts in fraud as shortages are resolved? 
Jessica Johnson: As our team watches these trends, we can see that counterfeit GLP-1s are not limited to when the drug is in shortage, but the shortage of legitimate GLP-1 drugs has increased the number of counterfeit GLP-1-related cases. When patients are unable to get a GLP-1 drug, whether it’s to treat diabetes or obesity, they may look to alternative sources for fulfillment. This is often the case when insurance doesn’t cover the medication or when patients seek out the medication without a valid prescription. Counterfeit GLP-1 schemes do not slow down when shortages are resolved. On the contrary, alternative schemes appear to be on the rise, targeting patients in different ways and building on past falsehoods. For example, patients may use online telehealth services to obtain these medications, leaving them susceptible to obtaining counterfeit or compounded medication. In these instances, they may not be talking to a provider. Members are also not always utilizing their local pharmacies to obtain these medications, leading to duplicate therapy or interactions risks. 

How do compounded formulations play into fraud?  
Compounded formulations may seem legitimate; however, many compounded formulations use bulk drug components that may not be FDA approved or perhaps contain incorrect ingredients altogether. For example, some fraudulent GLP-1s contain insulin, which has been used as an additive instead of the common active ingredients contained in GLP-1 products, which stimulate the pancreas to naturally produce insulin. In general, patients should be cautious when considering compounded forms of GLP-1 drugs.

What are some of the health implications of using counterfeit GLP-1s? 
These medications are not subject to the same safeguards as other prescription drugs, and there are risks for dosing/potency errors and the presence of substitute or even toxic ingredients that could lead to adverse effects for the patient. Some risks associated with counterfeit GLP-1s can include unregulated blood glucose levels or even infection at injection site as a result of tampered needles. Unregulated blood glucose levels are especially dangerous for patients diagnosed with diabetes. Over time, high blood glucose levels can lead to other systemic complications, which can be life threatening. Additionally, these counterfeit products can be ineffective altogether.

What are some of the most common ways to identify fraudulent GLP-1s? 
Some red flags include online pharmacies/providers not accepting insurance for the GLP-1 medications or not allowing you to choose your own pharmacy. Inspecting the product label is important in identifying counterfeit medication. Often times, we’ll see counterfeit products with labels that have been poorly printed, missing drug information or with the name of the drug misspelled. The FDA’s website allows patients and consumers to verify serial and lot numbers to ensure their medications are valid.

What should a member do if they suspect they have a fraudulent GLP-1? Do you have any recommendations or resources? 
If patients suspect counterfeit GLP-1 medications, they should not administer them and should contact their primary care provider or local pharmacy. The FDA also has resources to look up licensed pharmacies and safety tips if you do have to utilize an online platform. The FDA and World Health Organization websites also have resources and alerts of counterfeit medications.  

Read the report.